MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA INFRARENAL

Model Number	A34-34/C80 V
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2016, the patient was initially implanted with a bifurcated stent and an infrarenal extension.On (b)(6) 2017, endologix was made aware of migration of the infrarenal extension with no endoleak or sac growth.The patient was reported as stable and is being monitored.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to refute the reported event of migration of 8 to 10 mm as it was stent movement of 4mm instead.Clinical was also found evidence to support the additional finding of a type 1a endoleak with sac growth.The most likely cause of the cuff movement into the sac and loss of seal was the suboptimal placement at the implant within a hostile neck anatomy.Off-label neck anatomy suspected but could not be confirmed.There was no evidence of secondary procedure.The patient was reported to be in stable condition.To date there has been no reports of further negative patient sequelae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.Health professional: change to yes.(b)(4).

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7167611
• Report Number: 2031527-2018-00022
• Device Sequence Number: 16642779
• Product Code: MIH
• UDI-Device Identifier: 00818009013545
• UDI-Public: (01)00818009013545(17)191111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2019
• Device Model Number: A34-34/C80 V
• Device Lot Number: 1614510-007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT # 1596320-005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR